Medical Device And Its Construction

ABSTRACT

A tube can include an elongated cannulated member that has an external wall. The tube can be navigated during a selected procedure. The tube can be shaped to selected configurations.

FIELD

The application is a divisional of U.S. patent application Ser. No.13/871,616 filed on Apr. 26, 2013. The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The subject disclosure is related generally to a medical instrument, andparticularly to a cannulated tube having an internal coating.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

Instruments can be used to perform various procedures on a patient. Forexample, a probe can be positioned within a portion of a patient such asfor probing or moving tissue. In a further example, an elongated tubecan be placed for removing fluid or material from a patient, such as toremove resected tissue from a patient.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

A tube can include an elongated cannulated member that has an externalwall. The tube can have a selected internal diameter and externaldiameter based upon various selected features, such as a selectedposition for operation of the tube and volume and rate of removal orapplication of material with the tube. For example, a tube may be usedfor an ear, nose, and throat (ENT) procedure that may have a relativelysmall internal and external diameter. In addition, a tube or otherinstrument can be used in any appropriate selected procedure, such as acannulated member and/or catheter for drug deliver or similar therapiesin a brain, heart, vascular system. Also, suction can be formed throughthe instrument in any appropriate procedure. Nevertheless, a tube of anyselected diameter can be used.

The tube can be formed in a selected length and shape. The user, such asa surgeon, may select to alter the shape of the tube. For example, thetube can be formed of a material that allows the user to bend the tubeto a selected geometry during use. Selected materials can includealuminum or aluminum alloys that provide appropriate bendingcapabilities, such as bending to a selected radius without crushing orcollapsing the internal diameter of the tube.

The tube may also be coated with a selected material to ensure thatdebris from the tube does not enter the patient. For example, aninternal biocompatible coating can be positioned on the tube such thatdebris from the tube will not enter the patient during suction and/orirrigation of the patient with the tube. The biocompatible coating canbe applied to the tube in a manner to ensure appropriate protection ofthe patient from debris.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a detail view of an assembled lined tube, according to variousembodiments;

FIG. 2 is an exploded view of the lined tube of FIG. 1;

FIG. 3 is a cross-section view of a lined tube, according to variousembodiments;

FIG. 4 is a top plan view of an exemplary malleable suction instrument,according to various embodiments;

FIG. 5 is a view of exemplary bent or formed configurations of theexemplary malleable suction instrument , according to variousembodiments;

FIG. 6A is a partial view of the distal region of an exemplary suctioninstrument illustrating an exemplary tracking device arrangement,according to various embodiments;

FIG. 6B is a partial view of the distal region of an exemplary suctioninstrument illustrating a further exemplary tracking device arrangement,according to various embodiments; and

FIG. 7 is an environmental view of an exemplary navigation systemaccording to the principles of the present disclosure, according tovarious embodiments;

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

With reference to FIG. 1, an elongated tube 20, according to variousembodiments, is illustrated. The elongated tube can include an externaldiameter of an external tube member 21 that is defined by an externalwall 22 from a selected dimension. The tube 20 can include an externalstructure, such as formed of a metal that has a thickness 24. The tubemember 21 can, therefore, include an internal diameter defined by aninner wall 26. Positioned within the tube 20 can be a selected coatingor liner 30 that has an external surface that contacts the internal wall26 of the tube member 21. An internal surface 32 of the liner 30 thendefines an internal diameter 36 of a bore 38 of the tube assembly 20.The liner 30, therefore, can include a thickness 34. The thickness ofthe metal 24 and the thickness of the liner 34 define the internaldiameter 36 of the tube 20. The tube 20 can extend between a first end40 and a second end 42 to define a length 44.

The external portion or tube member 21 that defines the external wall 22can be formed of a selected material that includes selected properties.For example, the tube 20 can be selected to have a selected malleabilityto allow the tube 20 to be shaped while maintaining the ultimateinternal diameter or at least a selected fraction thereof. Thus, thetube 20 can be bent without kinking or collapsing. Materials can beselected for the tube member 21, such as aluminum or aluminum alloysincluding AL 3003-O, sold by International Tube having a place ofbusiness at 1500N CR 1850E Villa Grove, Ill. The aluminum or aluminumalloys can be selected to achieve or allow for a selected malleabilityor bendability of the tube 20. The tube 20 can be formed to achieve aselected radius without crushing or closing the bore 38 or substantiallyreducing the internal diameter 36 of the tube 20. For example, the smallsuction has a bend radius of about 8 millimeters (mm) from thecenterline and this can be achieved with the tube 20 formed of analuminum as the external tube 21 while maintaining at least a selectedinternal diameter. The overall bend radius is a function of the outerdiameter and the tube's wall thickness. In this example, the outerdiameter may be, for example, about 2 mm to about 3 mm, the innerdiameter may be about 1 to about 2 mm, and the wall thickness may beabout 0.1 to about 1 mm. In one example, the outer diameter of the tube21 may be about 2.3 mm, the wall thickness about 0.4 mm, and the innerdiameter about 1.4 mm. In other words, the tube 20 will generally notkink or the internal cannula will not collapse.

For various applications, however, an aluminum material may be selectedto have minimal contact with an environment. For example, an irrigationor suction tube used during an ear, nose and throat (ENT) procedures maybe selected to have minimal contact or introduction of debris from thealuminum tube into a human patient or other animal patient. It isunderstood that other procedures can also be performed or that anyappropriate instrument can be formed to include a coating or covering asdisclosed herein. Accordingly, the internal liner 30 can be applied tothe internal diameter or internal wall 26 of the aluminum tube 21 tominimize or eliminate contact or debris introduction from the aluminumtube 21 into a patient. The liner can be applied to the metal tube 21 toensure that no debris or abrasion occurs at the internal wall 26 of thetube member 21 to ensure that debris from the tube member 21 is notintroduced to the patient.

With reference to FIG. 2, the liner 30 can include an external wall 50that can contact and adhere to the internal wall 26 of the tube member21. The contact of the liner 30 with the tube member 21 can cause theliner 30 to adhere to the internal wall 26 of the tube member 21. Theadhesion of the liner 30 to the internal wall 26 of the tube member 21can be performed in an appropriate manner and manufacturing process.Selected manufacturing processes include application of an adhesive,extruding the liner 30 into the tube member 21, co-extruding the tubemember 21 with the liner 30, or other processes. The liner 30, however,can be affixed to the internal wall 26 of the tube member 21 tosubstantially line and protect the tube member 21 from contact with thepatient. It is also understood that the external wall 22 of the tube 21can be covered with a selected coating, such as the material of theliner 30 or other selected materials. For example, as discussed furtherherein, a selected shrink-wrap (also referred to as heat shrink)material can be bonded to the external wall 22 of the tube member 21 tofix in place various structures, such as circuitry, helical wires,and/or navigation tracking devices.

According to various embodiments, the liner 30 can be fixed to theinternal wall 26 of the tube member 21 by a pressure and bondingprocess. For example, the liner 30 can be positioned within the tubemember 21, as illustrated in FIG. 1. The tube 20 can then be sealed atone end, such as the end 42, and a fluid source can be introduced intothe first end 40 of the tube member 21, such as air or a selectedliquid. The fluid can be pressurized within the tube member 21 to applya force of the liner 30 into the internal wall 26 such that the externalwall 50 of the liner 30 is forced against the internal wall 26 of thetube member 21. According to various embodiments, in addition to thepressure, the combination of the tube member 21 and the liner 30 can beheated to a selected temperature, such as about 105° C. (about 221° F.),but can include a heating the tube to within about 90° C. to about 120°C. (about 194° F. to about 248° F.). The pressure can be applied on theliner 30 into the tube member 21 along with the heat for a selectedtime, such as about 8 minutes (mins.) to about 13 mins. As an example,the pressure inside the liners may be set to about 90±10 PSI (about620±70 kPa) for an exemplary tube having a size of 7 French, about 80±5PSI (about 558±35 kPa) for an exemplary tube having a size of 9 French,and about 40±5 PSI (about 275±35 kPa) for the an exemplary tube having asize of 12 French.

After the selected period of time, the pressure can be removed, such asby removing the selected fluid from within the liner 30 and the heat canbe removed from the combination of the liner 30 and the tube member 21.The liner 30 can, therefore, be fixed within the tube member 21 with thepressure and heat process. Generally, the liner 30 is adhered or bondedto the internal wall of the tube member 21 with enough strength toresist coming loose during bending of the tube 20 alone or incombination with suction and/or irrigation through the tube 20. Inaddition, a stylet or substantially stiff member may contact the linerwhile removing blockages without dislodging the liner. The suctionand/or irrigation can be provided by commonly used suction sources forsurgical procedures provided in hospitals. It is understood, however,that the tube m21 may form a portion of an instrument that may also beconnected to a power console, such as the Integrated Power Console IPC®system sold by Medtronic, Inc.

In addition, the internal wall 26 of the tube member 21 can be modified,such as by abrasion or etching to increase bonding strength of the liner30 with the internal wall 26. For example, a solution of ferric chloride(about 40% by weight and 1% by weight HCl) can be used to etch theinternal wall 26. Additionally, mechanical methods can be used to etchor abrade the internal wall 26. This can increase a surface area forbonding of the external wall 50 with the etched internal wall surface26. It is further understood, however, that the internal surface of thetube 21 may be unnetched and/or polished prior to placing the linerwithin the tube 21.

The liner 30 can be selected material, such as polyether block amides,such as those PEBAX® materials sold by Arkema, Inc., having a place ofbusiness in France. Other appropriate materials for the liner 30 caninclude linear low-density polyethylene and polypropylene homopolymers,such as the PROFAX polypropylene homopolymers sold by variousdistributors and manufacturers. The selected material for the liner 30can generally be selected to be flexible, wear and tear resistant, andachieve appropriate bonding with the internal wall 26 of the tube member21.

Additionally, co-polymers or co-extruded liners 30 can also be providedor formed. For example, a coextruded liner 30 can be adhered or bondedto the internal wall 26 of the tube member 21. In a co-extrudedconstruction an outer surface of the liner can be formed of a “sticky”material while the internal surface is formed of a smooth and/or hardermaterial. For example, “sticky” PEBAX® 2533 may be co-extruded on theoutside of “smooth” PEBAX® 6333 on the inside. Co-extrusion can beperformed in any appropriate known co-extrusion process.

The liner thickness 34 of the liner 30 can be selected for variousproperties, but may be selected to be about 0.127 millimeters (mm) toabout 0.254 mm thick. For example, a thickness of about 0.127 mm ensuresthat the liner 30 is at least as flexible as the tube 21 and remains inplace within the tube assembly 20.

According to various embodiments, with reference to FIG. 3, a tube 120is illustrated. The tube 120 can include two external portions,including a first external tube portion (or malleable portion) 122 and asecond external tube portion (or insert) 124. The two external portions122 and 124 can be formed of a single selected material or of differentselected materials. As illustrated in FIG. 3, the first external portion122 can include an external diameter and a central bore having aninternal diameter 126 defined by an internal wall 128. The firstexternal portion 122 can further define a second internal diameter by asecond internal wall portion 130. The second wall 130 can engage orreceive the second external portion 124. For example, as illustrated inFIG. 3, the second external portion 124 can include an external diameteror surface that is received and engaged in the second internal diameterdefined by the wall 130 of the first external portion 122. The secondexternal portion 124 can be fixed into the first external portion 122according to various embodiments, such as through an adhesive, braising,welding, or other fixation mechanisms.

According to various embodiments, the first external portion 122 can beformed of a first material while the second external portion 124 isformed of a second material. It is understood, however, that the firstexternal portion 122 and the second external portion 124 can also beformed of the same material. According to various embodiments, the firstexternal portion 122 can be formed of an aluminum or aluminum alloy,similar to those discussed above. The second external portion 124 can beformed of a steel or steel alloy, including generally known inbiocompatible stainless steel alloys. The first external portion 122 cantherefore include various malleable features, including those discussedabove. The second external portion 124 can be more rigid or stiff forvarious purposes, including those discussed herein.

The tube 120, however, can include a substantially continuous internaldiameter through the first external portion 122 and the second externalportion 124 or an appropriate variable internal diameter. Nevertheless,the second external portion 124 can include or have an internal wall 140that defines the internal diameter 126. Positioned within the internaldiameter and on the first wall 128 of the first external portion 122 andthe second wall 140 of the second external portion 124 can be a liner150.

The liner 150 can be substantially similar to the liner 30 discussedabove and include an external wall or surface 152 to engage the internalwall 140 of the second external portion 124 and the internal wall 128 ofthe first external portion 122. Additionally, the liner 150 can beaffixed or adhered to the tube 120 similar to the method as discussedabove for fixing the liner 30 within the tube member 21. The liner 150can have a selected thickness, as discussed above. The liner, therefore,can define an internal diameter 170 of a bore 172 of the tube assembly120.

According to various embodiments, the liner 150 can extend from the endsor open ends of the tube 120, such as the first end 156 and the secondend 158, to engage a wraparound an exterior surface of the tube 120. Forexample, the liner can extend around into an exterior of the tube 120 atthe first end 156 a first liner extension portion 160 and around thesecond end 158 of the tube 120 at a second liner extension portion 162.The liner extension portions 160 and 162 can be adhered to the tube 120in a similar manner as discussed above. Additionally, it is understoodthat a tube, such as the tube 20 illustrated above in FIGS. 1 and 2, canalso include portions of the liner 30 that extend exterior to theinternal surface 26 of the tube member 21, such as over an exteriorsurface 22 thereof. Accordingly, the liner can extend onto an externalsurface of a tube whether the tube is formed as a single one-piecemember or formed of multiple portions, as illustrated in FIG. 3.

In addition, an entire exterior of the tube, including the tube 20 andthe tube 120, can be covered with the respective liners 30, 150.According to various embodiments, however, an external surface of therespective tubes, can be covered by other materials. For example, a heatshrink wrap 300 (FIG. 3), can be used to cover the tube 21. The heatshrink wrap can include heat shrink wrap such as that disclosed in U.S.patent application Ser. No. 13/751,032 filed on Jan. 25, 2013,incorporated herein by reference.

Referring now to FIGS. 4-7, and continuing reference to FIGS. 1-3, thelined tube, according to various embodiments, can be included or used asa navigated malleable surgical instrument 200, as will be described ingreater detail herein. In one exemplary embodiment, the malleablesurgical instrument 200 can be used for suction, including fluid andtissue removal during ENT procedures. Again, it is understood that thesuction tube can be used for any appropriate procedure or that otherappropriate instruments can be covered as discussed herein. It will beappreciated, however, that the navigated malleable surgical instrument200 can be used in various other surgical procedures as may be desiredand can be provided in the form of a malleable or flexible endoscope, amalleable or flexible catheter, and/or a malleable or flexiblecannulated member. Thus, while the following description continues withreference to a navigated malleable suction instrument 200, thediscussion is also applicable to the various surgical instruments, asdiscussed above.

Accordingly to various embodiments, as illustrated in FIG. 4, a tube,such as the tube 120 can be used with the navigated malleable suctioninstrument 200 (also referred to as instrument 200 herein) that includesa handle or graspable portion 214 for manipulation by a user, asillustrated in FIG. 7. It is further understood that the tube 20 canalso be used with the handle portion 214 and the following discussion ofthe tube 120 is merely exemplary. A connector 284, such as a suction orirrigation source connection, can extend from the handle 214. Also acable connector 258 can extend from the handle 214. The cable connector258 can allow for connection of one or more tracking devices 250 (FIG.6A) and/or tracking devices 250′ (FIG. 6B) to various systems, such asthe tracking system discussed herein. The tube 120 can be malleableand/or shapeable as illustrated in FIG. 5. Also, according to variousembodiments, the tube 120 can also include various tracking devices,including the tracking devices 250, 250′ as illustrated in FIG. 6Aand/or 6B. Accordingly, a user, as illustrated in FIG. 7, can bend thetube 120 to various configurations for use in a procedure, includingthat as disclosed in U.S. patent application Ser. No. 13/751,032 filedon Jan. 25, 2013, incorporated herein by reference. A brief descriptionof the use of the lined tube, according to various embodiments,including the tube 120, will be discussed herein.

The instrument 200 can be configured for a single use such that it wouldbe disposed after such use. The tube assembly 120 can include amalleable elongated tubular body, which can include the outer portion122. The tubular body 122 can include an outer diameter 123 and theinner diameter 126. The end 162 may be coupled to the handle assembly214 and the second opposite end 160 extends away from the handle 214.The second end of the first outer portion 122 may receive the secondouter portion 124 (also referred to as an insert) and/or be coupled tothe tracking device 250, as discussed herein. The malleable elongatedbody 122 can be formed from various aluminum alloys, such as AL 3003-O,sold by International Tube having a place of business at 1500N CR 1850EVilla Grove, Ill., such that it is malleable to facilitate being bent orformed into various configurations and retaining the bent or formedconfiguration, as will be discussed herein. The body 126 can also beprovided in various lengths and diameters, including 7, 9 and 12 Frenchdiameters.

The insert portion 124 can be configured to provide non-malleablesupport for at least the tracking device 250. Insert portion 124 caninclude an outer diameter defined by the wall 140 that is substantiallyequal to the inner diameter defined by the inner wall 130 and an innerdiameter that is substantially equal to the inner diameter 126 ofmalleable elongated body 122, as also shown in FIG. 3. In this manner,the substantially equal inner diameter 126 of both the first portion 122and the second portion 124 can provide for a substantially constant flowpath 220 for suction. It should be appreciated, however, that the innerdiameter can also be provided with varying dimensions.

The handle assembly 214 can include a suction adjustment feature 290which can be in the form of a bore 292 extending from an outer surface294 of the handle assembly 214 and into fluid communication with thesuction passage 220 through the tube 120. In operation, a surgeon oruser 50 of the instrument 200 can place their thumb or another objectover the bore 292 to vary an opening of the bore 292 and thus vary anamount of suction pressure realized in the flow path or passage 220. Forexample, if the bore 292 is left completely open or uncovered, amajority if not all of the suction will be through the bore 292 and notthe first end 156 of insert portion 130. On the other hand, if the bore292 is completely covered or closed off, a maximum amount of suctionwill be realized at end 172. Varying the opening of bore 292 betweenfully closed and fully opened can therefore correspondingly vary anamount of realized suction at end 156.

In operation and with additional reference to FIG. 5, the malleableelongated body 122 can be bent into various configurations, as generallyshown by the exemplary configurations 122 a-d. The malleable nature ofbody 122 can provide the ability for body 122 to be bent into suchvarious configurations without kinking and can maintain the variousconfigurations until bent or shaped into another configuration. In aninitial or selected configuration 122 a, the tube 120 can extend along asubstantially straight axis 270. The malleable tube 122 can be bent tothe non-straight configurations 122 b-d or other selectedconfigurations. Further, malleable body 122 can be bent or shaped asdiscussed above without requiring additional tools, such as a mandrel tofacilitate the bending. This is advantageous, for example, in that asurgeon can bend body 122 multiple times by hand during a procedure inclose proximity to the patient without having to resort to additionaltools or other equipment to facilitate the bending while performing theprocedure.

The tube assembly 120 can include a polymeric outer heat shrink 300covering the entire assembly, as shown in detail in FIG. 6A. Thus, theheat shrink 300 can cover the elongated body 122, the insert portion124, and the tracking device 250 including any wires or connectorsextending along the tube assembly 120, such as wires that may behelically wound along the body 122 as disclosed in U.S. patentapplication Ser. No. 13/751,032 filed on Jan. 25, 2013, incorporatedherein by reference. The heat shrink 300 can provide an outer coveringor shell over the tube assembly 120 and sensor arrangement 250 whileproviding sufficient flexibility for both bending of the body 122 andslight relative movement of any helically wound wires as a result of thebending. In this regard, the wires can be moveably captured between theheat shrink and the tubular body. The heat shrink covering can alsoserve as an electric isolation and/or physical barrier. Thus, the liner150 need not extend over the outside of the tube 120. It is understood,however, that the liner 150 may extend over the outside of the tube 120.

With further reference to FIG. 6A, the tracking device 250 is shownassociated with instrument 200. The tracking device 250 can include aplurality of oval coil assemblies positioned around the sleeve 124 nearthe distal tip 156. In one exemplary configuration, two to four coilassemblies can be positioned about sleeve 124 proximate distal tip 222.In the exemplary configuration illustrated, coil assemblies 250 a-c canbe circumferentially spaced around sleeve 124 near the distal tip 156,further an axial coil 304 can be positioned proximally of the coilassemblies 250 a-c, as shown in FIG. 6A. The axial coil can be woundaround the axis 270 of the tube assembly. Thus, as is understood in theart, at least six degrees of freedom of tracking information can bedetermined regarding the distal end 156 of the tube 120. The coilassemblies 250 a-c can be formed in various selected shapes, such aselliptical, circular, or oval. A further discussion of coil assemblies250 a-c and axial coil 304 can be found in U.S. application Ser. No.13/016,740, filed on Jan. 28, 2011 and entitled “Method and Apparatusfor Image-Based Navigation”, incorporated herein by reference.

With reference to FIG. 6B a further exemplary tracking device 250′ isillustrated. It is understood that the tracking device 250′ can be usedseparately or in conjunction with the tracking device 250. The trackingdevice 250′ is described in detail in U.S. patent application Ser. No.13/751,032 filed on Jan. 25, 2013, incorporated herein by reference, andwill be described briefly here. Generally, the tracking device 250′ caninclude tracking device members 250′a-c that are associated with aninstrument 200′, similar to the instrument 200 discussed above. Theinstrument 200′ and/or a tube 120′ can be substantially similar and/oridentical to the instrument 200 and tube 120 discussed above. Thetracking device 250′ may be provided in a different configuration. Forexample, the tube 120′ can include an insert portion 124′ that can beconfigured to provide non-malleable support for at least the trackingdevice 250′ and a selected internal and external diameter as discussedabove. The insert can include a selected number of grooves 310 a, 310 bto receive the tracking devices 250′a-c. The grooves 310 a, 310 b can beformed in flattened sides 312 a, 312 b of the insert 124′. Connections314 can be provided between the tracking devices 250′ and the navigationsystem 400 as discussed above and herein. The tube 120′ can include aliner 30′ similar and/or identical to the liner 30 discussed above alongwith the heat shrink 300. Thus, the tracking device assembly 250′ mayalso be used, alternatively and/or in combination with the trackingdevice 250.

FIG. 7 is a diagram schematically illustrating an environmental view ofan image-guided navigation system 400 for use in the non-line-of-sitenavigating of a surgical instrument 200, such as a navigable malleablesuction device or suction instrument, according to various exemplaryembodiments of the present disclosure. Exemplary navigation systemsinclude those disclosed in U.S. Pat. No. 7,366,562, issued on Apr. 29,2008 to John H. Dukesherer et al. and U.S. Pat. App. Pub No.2008/0132909, published Jun. 5, 2008, to Bradley A. Jascob et al., bothincorporated herein by reference. Commercial navigation systems includethe StealthStation® AxiEM™ Surgical Navigation System sold by MedtronicNavigation, Inc. having a place of business in Louisville, Colo., USA.It should be appreciated that while the navigation system 400 andsuction instrument 200 are generally described in connection with anear, nose and throat (ENT) procedure, navigation system 400 and suctioninstrument 200 can be used in various other appropriate procedures.

Generally, the navigation system 400 can be used to track a location ofan exemplary suction instrument 200, including the distal tip 156thereof. The instrument 200 can include an exemplary flexible printedcircuit sheet (not illustrated). Navigation system 400 can generallyinclude an optional imaging system 410, such as a fluoroscopic X-rayimaging device configured as a C-arm 412 and an image device controller414. The C-arm imaging system 410 can be any appropriate imaging system,such as a digital or CCD camera, which are well understood in the art.Image data obtained can be stored in the C-arm controller 414 and sentto a navigation computer and/or processor controller or work station 416having a display device 418 to display image data 40 and a userinterface 420. It is understood that any appropriate image data (e.g.magnetic resonance image data, computed tomography image data, SPECTimage data, etc.) can be acquired of the subject pre-operatively and/orintra-operatively for use with the navigation system 400.

The work station 416 can also include or be connected to an imageprocessor, navigation processor, and a memory to hold instruction anddata. The work station 416 can include an optimization processor thatassists in a navigated procedure. It will also be understood that theimage data is not necessarily first retained in the controller 414, butmay also be directly transmitted to the workstation 416. Moreover,processing for the navigation system and optimization can all be donewith a single or multiple processors all of which may or may not beincluded in the work station 416.

The work station 416 provides facilities for displaying the image data420 as an image on the display device 418, saving, digitallymanipulating, or printing a hard copy image of the received image data.A user interface 424, which may be a keyboard, mouse, touch pen, touchscreen or other suitable device, allows a physician or user 430 toprovide inputs to control the imaging device 410, via the C-armcontroller 414, adjust the display settings of the display device 418,and/or otherwise control the navigation system 400.

The navigation system 400 can further include a tracking system, such asan electromagnetic (EM) tracking system 440. The discussion of the EMtracking system 440 can be understood to relate to any appropriatetracking system. The EM tracking system 440 can include a localizer,such as a coil array 442 and/or second coil array 444, a coil arraycontroller 450, a navigation probe interface 452, and the trackablesuction instrument 200. Instrument 200 can include the instrumenttracking device or devices 250. The tracking device 250 can include anelectromagnetic coil to sense a field produced by the localizing coilarrays 442, 446 and provide information to the navigation system 400 todetermine a location of the tracking device 250. The navigation system400 can then determine a position of the distal tip 156 of the suctioninstrument 200 to allow for navigation relative to a patient 460 andpatient space.

The EM tracking system 440 can use the coil arrays 442, 446 to create anelectromagnetic field used for navigation. The coil arrays 442, 446 caninclude a plurality of coils that are each operable to generate distinctelectromagnetic fields into the navigation region of the patient 460,which is sometimes referred to as patient space. Representativeelectromagnetic systems are set forth in U.S. Pat. No. 5,913,820,entitled “Position Location System,” issued Jun. 22, 1999 and U.S. Pat.No. 5,592,939, entitled “Method and System for Navigating a CatheterProbe,” issued Jan. 14, 1997, each of which are hereby incorporated byreference.

The localizers 442, 446 can be controlled or driven by the coil arraycontroller 450. The coil array controller 450 can drive each coil in thelocalizers 442, 446 in a time division multiplex or a frequency divisionmultiplex manner. In this regard, each coil may be driven separately ata distinct time or all of the coils may be driven simultaneously witheach being driven by a different frequency.

Upon driving the coils in the localizers 442, 446 with the coil arraycontroller 450 electromagnetic fields are generated within the patient460 in the area where the medical procedure is being performed, which isagain sometimes referred to as patient space. The electromagnetic fieldsgenerated in the patient space induce currents in the tracking device250 positioned on or in the suction instrument 200. These inducedsignals from the tracking device 250 can be delivered to the navigationprobe interface 452 and subsequently forwarded to the processor 416. Thenavigation probe interface 452 can also include amplifiers, filters andbuffers to directly interface with the tracking device 250 in theinstrument 200. Alternatively, the tracking device 250, or any otherappropriate portion, may employ a wireless communications channel, suchas that disclosed in U.S. Pat. No. 6,474,341, entitled “SurgicalCommunication Power System,” issued Nov. 5, 2002, herein incorporated byreference, as opposed to being coupled directly to the navigation probeinterface 450.

The tracking system 440, if it is using an electromagnetic trackingassembly, essentially works by positioning the localizers 442, 446adjacent to the patient 460 to generate an electromagnetic field, whichcan be low energy, and generally referred to as a navigation field.Because every point in the navigation field or patient space isassociated with a unique field strength and directions, theelectromagnetic tracking system 440 can determine the position of theinstrument 200 by measuring the field strength and directions orcomponents thereof at the tracking device 250 location. The coil arraycontroller 450 can receive the induced signals from the tracking device250 and transmit information regarding a location, where locationinformation can include degree of freedom information, including x, y,and z position and roll, pitch, and yaw orientation information, of thetracking device 250 associated with the tracked suction instrument 200.Accordingly, six degree of freedom (6 DOF) information can be determinedwith the navigation system 400.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

What is claimed is:
 1. A method of forming an instrument system,comprising: providing a cannulated member extending from a first memberend to a second member end, the cannulated member formed of at least afirst material; providing a liner member extending from a first linerend to a second liner end; and bonding the provided liner to an internalwall of the cannulated member; wherein the bonded liner inhibits debrisfrom the cannulated member exiting the cannulated member.
 2. The methodof claim 1, wherein providing the cannulated member includes providing afirst cannulated member inserted into a second cannulated member,wherein the first cannulated member and the second cannulated memberdefine a single internal bore.
 3. The method of claim 2, furthercomprising: providing the first cannulated member formed of a secondmaterial that is stiffer than the first material from which the firstcannulated member is formed.
 4. The method of claim 3, wherein the firstmaterial includes an aluminum.
 5. The method of claim 4, wherein bondingthe provided liner to the internal wall of the cannulated memberincludes bonding the liner to both a first internal wall of the firstcannulated member and a second internal wall of the second cannulatedmember.
 6. The method of claim 5, wherein bonding the provided liner tothe internal wall of the cannulated member includes: placing the linerwithin the cannulated member; pressurizing the liner to force anexternal wall of the liner to contact the first internal wall and thesecond internal wall.
 7. The method of claim 6, further comprising:heating the cannulated member while pressurizing the liner to force anexternal wall of the liner to contact the first internal wall and thesecond internal wall.
 8. The method of claim 7, further comprising:etching the first internal wall and the second internal wall prior toplacing the liner within the cannulated member.
 9. The method of claim7, further comprising: polishing the first internal wall and the secondinternal wall prior to placing the liner within the cannulated member.10. The method of claim 1, further comprising: providing the linerformed of at least one of a polyether block amides, linear low-densitypolyethylene, or polypropylene homopolymers.
 11. The method of claim 1,further comprising: bonding the liner to at least a portion of anexternal wall of the cannulated member near at least one of the firstmember end or the second member end.
 12. The method of claim 1, furthercomprising: providing the liner formed as a co-extrusion of an exteriorsticky material and in internal smooth material; wherein bonding theprovided liner to the internal wall of the cannulated member includescontacting the exterior sticky material to the internal wall of thecannulated member.
 13. The method of claim 1, further comprising:bonding a first liner extension portion extending around the firstmember end and bonding a second liner extension portion extending aroundthe second member end of the cannulated member.
 14. The method of claim13, further comprising: covering an external wall of the cannulatedmember with an exterior member.
 15. The method of claim 14, furthercomprising: heat shrinking the exterior member to the cannulated member.16. The method of claim 1, wherein bonding the provided liner member tothe internal wall of the cannulated member further includes co-extrudingthe cannulated member and the liner member.
 17. The method of claim 1,wherein at least a portion of the cannulated member is bendable and theliner member is bonded to the cannulated member to resist coming loseduring bending.
 18. The method of claim 3, wherein the first cannulatedmember is fixed to the second cannulated member by way of adhesive,braising, or welding.
 19. The method of claim 1, further comprising:attaching a handle to the cannulated member.
 20. The method of claim 19,wherein the cannulated member is bendable and used as a suction orirrigation tube.